TMC125IFD1001 - Drug-Drug Interaction of Etravirine With Telaprevir and TMC278 With Telaprevir.
2012年8月28日 更新者：Tibotec Pharmaceuticals, Ireland
A Phase I, Open Label, Randomized, 2-Panel, 2-Way Crossover Trial to Investigate the Pharmacokinetic Interaction Between Etravirine or TMC278 and Telaprevir at Steady-State in Healthy Subjects.
The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed into the body when administered together.
調査の概要
詳細な説明
This is an open-label, randomized, single-dose, crossover trial in healthy volunteers.
Crossover means that participants may receive different interventions sequentially during the trial.
Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin.
Open-label means that you and your physician will know what treatment you will receive.
The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase.
Total study duration for an individual participant will be approximately 11 weeks.
Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase.
In the first part, a group of 16 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance.
In treatment A, 200 mg (2 tablets) ETR (etravirine) will be given twice a day from day 1 to 10 with a morning dose only on day 11.
In treatment B, 750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 17 every 8 hours with a morning and afternoon dose only on day 18 and 200 mg ETR will be given twice a day from day 8 to 17 with a morning dose on day 18.
In between the 2 sessions, there will be at least 14 days.
In the second part, another group of 16 participants will receive 2 treatment sessions, C and D. The order in which these treatments are given will be determined by chance.
In treatment C, 25 mg (1 tablet) TMC278 will be given once a day from day 1 to 11.
In treatment D, 750 mg (2 tablets) TVR (telaprevir) will be given from day 1 to 18 every 8 hours and 25 mg TMC278 will be given once a day from day 8 to 18.
In between the 2 sessions, there will be at least 14 days.
All treatments will be taken food.
In treatments A and C, participants will come to the unit the day before dosing and in the mornings of day 1, 9 and 10 and for a whole day on day 11.
Only in treatment C, overnight stay from day 11 to day 12 is foreseen.
In treatment B, participants will come to the unit the day before dosing and in the mornings of days 1, 5, 6, 8, 16 and 17 and for a whole day on days 7 and 18.
In treatment D, participants will come to the unit the day before dosing and in the mornings of days 1, 5, 6, 8, 12, 16 and 17 and for a whole day on days 7 and 18 with overnight stay from day 18 to 19.
Five to 7 days after last dosing, participants will have a last follow-up visit at the unit (follow-up phase).
During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drugs).
In treatment A, 2 tablets ETR will be given twice a day from day 1 to 10 with a morning dose on day 11.
In treatment B, 2 tablets TVR will be given every 8 hours from day 1 to17 with only 2 doses on day 18 and 2 tablets ETR twice a day from day 8 to 17 with a morning dose only on day 18.
In treatment C, 1 tablet TMC278 will be given oncy a day from day 1 to 11.
In treatment D, 2 tablets of TVR will be given every 8 hours from day 1 to 18 and 1 tablet TMC278 once a day from day 8 to 18.
研究の種類
介入
入学 (実際)
33
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Antwerp、ベルギー
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～55年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
- A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2
- Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at Screening
- Women must be postmenopausal for at least 2 years or be surgically sterile or be not heterosexually active for the duration of the study, or have a vasectomized partner, or if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control.
Exclusion Criteria:
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
- A positive urine drug test at Screening
- Use of disallowed therapies: concomitant medication, including over-the-counter products, herbal preparations and dietary supplements
- History of significant drug allergy
- Received an investigational drug or used an investigational medical device within 60 days preceding the first intake of study medication or having previously participated in a study with either ETR, TMC278, telaprevir.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：001
ETR/telaprevir Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11.
Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18 and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.
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Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11.
Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.
|
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実験的：002
telaprevir/ETR Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11.
Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18 and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.
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Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11.
Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.
|
|
実験的：003
TMC278/telaprevir Treatment C: TMC278 25 mg once day from Day 1 to Day 11.
Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18 and TMC278 25 mg once daily from Day 8 to Day 18.
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Treatment C: TMC278 25 mg once day from Day 1 to Day 11.
Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.
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実験的：004
telaprevir/TMC278 Treatment C: TMC278 25 mg once day from Day 1 to Day 11.
Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18 and TMC278 25 mg once daily from Day 8 to Day 18.
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Treatment C: TMC278 25 mg once day from Day 1 to Day 11.
Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Bloodlevels of telaprevir following co-administration with ETR
時間枠：Over 8 hours on day 18 of treatment B.
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Over 8 hours on day 18 of treatment B.
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Bloodlevels of telaprevir following co-administration with TMC278
時間枠：Over 8 hours on day 18 of treatment B.
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Over 8 hours on day 18 of treatment B.
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Bloodlevels of ETR following co-administration with telaprevir
時間枠：Over 12 hours on day 18 of treatment B.
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Over 12 hours on day 18 of treatment B.
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Bloodlevels of TMC278 following co-administration with telaprevir
時間枠：Over 24 hours on day 18 of treatment D
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Over 24 hours on day 18 of treatment D
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Number of participants with adverse events and the severity of adverse events
時間枠：Over approximately 11 weeks
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Over approximately 11 weeks
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Bloodlevels of ETR in function of variations of 2 genes (CYP2C9 and CYP2C19)
時間枠：1 bloodsample on day 1 of treatment A.
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1 bloodsample on day 1 of treatment A.
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Observed values and changes from baseline for abnormal values of laboratory results.
時間枠：Over approximately 11 weeks
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Over approximately 11 weeks
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Observed values and changes from baseline for electrocardiograms (interpretation of electrical activity of the heart)
時間枠：Over approximately 11 weeks
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Over approximately 11 weeks
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Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits
時間枠：Over approximately 11 weeks
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Over approximately 11 weeks
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Physical examination findings and changes from baseline.
時間枠：Over approximately 11 weeks
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Over approximately 11 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年3月1日
一次修了 (実際)
2011年9月1日
研究の完了 (実際)
2011年9月1日
試験登録日
最初に提出
2011年4月7日
QC基準を満たした最初の提出物
2011年4月15日
最初の投稿 (見積もり)
2011年4月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年8月29日
QC基準を満たした最後の更新が送信されました
2012年8月28日
最終確認日
2012年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CR017989
- TMC125IFD1001 (その他の識別子：Tibotec Pharmaceuticals, Ireland)
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